MEETING NOTES
THERAPEUTIC PRODUCTS PROGRAMME
ADVISORY COMMITTEE ON MANAGEMENT
TPP Boardroom
Holland Cross, Tower B, 1600 Scott Street
Ottawa, Ontario
January 17- 18, 2001
Members:
Jim Blackburn (Chair)
Luis Barreto
Andrea Baumann
John Blatherwick
Robert Goyer
Ruby Grymonpre
Mitchell Levine
Stuart MacLeod
Kenneth Michalko
Brenda Nunns-Shoemaker
John Parks
Jack Rosentreter
Bonnie Salsman
John Stewart
Pamela Zabe
Regrets:
Malcolm Seath
Beverley Townsend
Secretariat:
Robert Peterson
Marion Law
Denise Quesnel
Carolin Vaughn
Presenters:
Marta Caris
Ross Duncan
Sultan Ghani
Geoff Middleton
Brigitte Zirger
Observers:
Barbara Benning
Dennis Brodie
Danièle Dionne
Julia Hill
Jean Peart
1. Opening Remarks (J. Blackburn)
Dr. Blackburn welcomed everyone, thanked the new members
for agreeing to serve on the Committee and the previous members for
their continued support. A roundtable of introductions followed.
Dr. Peterson indicated that the TPP has finalised the
operational planning for 2000-2001. This will involve a review of many
aspects of the Programme including the need to discuss the role of ACM
with respect to the two new Directorates. TPP proposed topics that would
require a new kind of support and involvement as the realignment activities
move forward. There are some international and domestic challenges that
will need to be addressed (legislative renewal is one example). It is
clear that the role of external bodies is necessary to support the work
of the new realignment Programmes. This being accomplished, the focus
is to move ahead with realignment.
2. Review of the August 24th Meeting Notes (J. Blackburn)
The meeting notes of August 2000 were approved as presented.
3. ACM Membership (J. Blackburn)
Three new members have joined the ACM:
Dr. Mitchell Levine, Director, Centre for Evaluation
of Medicines,
St. Joseph's Hospital, Hamilton, Ontario, as a nominee
from the Canadian Medical Association;
Dr. Kenneth Michalko, Senior Director, Regulatory
Affairs, Novopharm, Stouffville, Ontario (and Teva Marion Partners Canada,
Montreal, Quebec), as a nominee of the Canadian Drug Manufacturers Association;
Mr. Jack Rosentreter, Director, Pharmaceutical
Consulting Group, Manitoba Health, Winnipeg, Manitoba, as a nominee
of the Pharmaceutical Issues Committee (PIC).
4. TPP's financial situation as we move towards realignment
(G. Middleton)
G. Middleton presented the 2000-2001 budget, and the
operational planning challenges that the TPP is facing with the realignment.
Cash management, realignment, targeted funding and cost recovery were
identified as issues impacting resources/funding. The cost recovery
shortfall is forecast to be $4.4 M. This is an ongoing problem relating
primarily to changes made to the Medical Devices. It is hoped to work
towards resolving this issue during the coming fiscal year. TPP's
financial situation as we move towards realignment (continued)
For the benefit of new members, Dr. Peterson explained
the complex process of revenue collection through cost recovery and
budget distribution, and appropriations for the operational plan of
the current fiscal year.
He indicated that without having to contend and shift
resources to address unexpected policy activities of previous years
(i.e. medicinal marijuana, industrial hemp), it has been easier this
year to prepare a more accurate operational plan. The operational planning
exercise for the new fiscal year will be challenging as the TPP moves
to operate as two new Directorates.
Some members expressed concerns with regards to the TPP
financial situation. Overall TPP is in a good position with a planned
expenditure budget of $74 M (approx.) against our anticipated budget
of $71.6M. And there may be a surplus at the end of the fiscal year,
but realignment would be responsible for that surplus. Any surplus during
the fiscal year will be considered for activities in support of the
realignment process. Staffing is also a priority and TPP is moving forward
to meet new regulatory obligations.
5. Realignment of Health Canada (R. Peterson)
The TPP will continue to operate as one Programme until
the end of this fiscal year (March 31st). Although aspects of the restructure
are beginning to be put in place, the split into two Directorates (Therapeutic
Products Directorate (TPD), and Biologic and Genetic Therapies (BGT)
should be final by
April 1, 2001. The new Branch, Health Products and
Food, has four principal directorates (Food, Office of Natural Health
Products, Biologic and Genetic Therapies, and Therapeutic Products)
with support from other Branch and offices. Some current TPP functions
(e.g. compliance and enforcement) may include more details of how the
Programme will move to serve the entire Health Products and Food Branch.
The Realignment action plan will consider other common activities and
determine if it is appropriate to have this capacity within each directorate
shared between Directorates or located at the Branch level. Post-marketing
activities is also another function which will be similarly considered.
The approach is to look at the challenges, and find a structure that
would achieve results without duplicating the resources and finances.
Status: Realignment has made it clear that the
TPP will no longer pursue Agency status. Dr. Peterson confirmed his
intention to stay with the TPP, and is actively looking to recruit a
new Director General for BGT. He is currently Acting Director General
for BGT. ACM members indicated that they would be willing to take an
active part in decision making.
Process: A two day Management Retreat was held
in November 2000, to discuss operational planning and the plan for the
Realignment of the TPP. An Extended Management Retreat was held
in January, 2001 (2 days/125 middle managers). This Retreat focused
on information sharing and helped with direction on the realignment
challenges, the proposed models and their varying implications, and
priorities. A transition team will be appointed.
Realignment of Health Canada (continued)
There are currently 930 positions in the TPP, 300 of which are not filled.
A full Human Resources review is expected.
Additional changes: There is a departmental initiative
to strengthen the regional functions. TPP already has regionalisation
within the current Bureau of Compliance and Enforcement (BCE). The Branch
will look at areas where functions/activities can be carried out in
the Region as well as Ottawa and also consider functions which may be
more successfully relocated to the Regions.
Mr. Ian Green is the newly appointed Deputy Minister.
Mr. Green had b support and the confidence of his predecessor Mr.
David Dodge.
6. Presentation on the new Branch structure
Diane Gorman, Assistant Deputy Minister of Health Products and Food
Branch
Ms. Gorman described the new organizational chart, presented
some of the challenges, and was then available for questions. She mentioned
that at the two day Strategic Planning Retreat, the challenges that
were identified are common across the Branch. She reported that the
new Deputy Minister supports the current realignment concept, and she
does not foresee any significant changes to the mandate and structure
proposed in the Re-alignment document.
Some of the principles for Realignment in the Branch
are:
- Manageable span of responsibilities (eg. creation of BGT);
- evolving importance of biologic and genetic therapies
Risk management - b horizontal issues management;
- continuum of risk for products for the purpose of maintaining and improving
health;
Branch functions to provide support and co-ordination;
Policy and Strategic Planning - to provide Branch framework and tools;
b regional capacity.
Challenges:
Knowledge capacity: The Branch must continue to build a knowledge capacity
to continued to forge more partnerships and create international opportunities
Increase in demands of new technologies: The Branch must
strive to become a leading edge capacity and must be more innovative
with partnerships.
Biotechnology: There is a great potential to increase
the health of Canadians, and we have to work to gain the public's trust.
Presentation on the new Branch structure / Challenges
(continued)
Office of Consumers Affairs and Public Involvement (OCAPI) : There is
an increased demand for public information. We have to be proactive
in risk communication to give freedom of informed choice.
Legislative renewal: It is the Branch's intention to
put this back on the political agenda. If this is successful, the next
stage is consultation.
Budget: 90% of the Branch's budget goes on staffing.
There is a need to look at targeted funding and how this impacts on
the budgetting process. In addition, we need to start focussing on establishing
Health Canada as a workplace of choice and to increase our commitment
to staff to encourage a healthy work/life balance.
Training was raised as a key factor to success. There is no University
course on government business, so we must invest and build capacity
by training for the longterm. Ms. Gorman recognized that training was
already being done on risk management.
Ms. Gorman discussed the role of the new Chief Scientist,
Dr. Kevin Keough. He will be an advisor to the Deputy Minister on science
issues. It is unlikely that he will deal with operational (science)
issues. Dr. Keough will be starting at Health Canada on April 1, 2001.
7. Discussion on TPP's Human Resource Strategy for the next year (B. Zirger)
B. Zirger reported on the progress since the August 2000 meeting. The
Human Resources Initiative (HRI) team and working groups are in place,
the recruitment initiatives have started, and the marketing efforts
are also well underway. An informal count shows that close to 100 vacancies
have been filled since July 2000. This is a very soft number that highlights
the need for a proper tracking system - a priority for the next few
months. The Recruitment Working Groups for the Medical Officers are
working on a special advertisement (for MOF positions) that will be
published in a number of journals between February 1 to 10, and mailed
to all physicians in the National Capital Region in mid-February.
The ACM members indicated concerns about the staffing
process. They feel that it is too cumbersome and lengthy and people
may be lost in the process to other positions.
The TPP has participated in job fairs (Post Secondary
Recruitment in the fall 2000) and are planning to attend the following:
- PSC's EE job fair - February 7th
- Canadian Federation on Biological Societies - June 2001
ACM members offered comments on how the MOF poster could
be changed to be more effective. While the version for the journals
had been frozen, members comments were reflected in the poster being
mailed to physicians in mid-February.
They are developing marketing materials and are proud
of their MOF Poster that will be published in February.
8. Update on Activities:
. Advisory Panel on the Product Licensing Review
Process (R. Goyer)
R. Goyer expressed the expectations and frustrations of this Panel.
Its role is to look at the recommendations from the HIV Working group
which include issues such as timeliness, transparency and post- marketing
surveillance. The Panel would like to be more than an advisory panel
and contribute more to the decision-making. It is not clear to them,
if this is their mandate. The next meeting is scheduled to April 23
and 24, 2001, in Ottawa.
. Public Advisory Committee (PAC) (M. Law)
This Group may evolve into a Branch public advisory group. To consider
this further, TPP will work with the PAC working group and the Branch
(OCAPI). An individual with credibility should lead PAC. The Office
of Consumer Affairs and Public Involvement (OCAPI) was established to
coordinate and support the public involvement activities for the Branch.
The TPP is anxious to support this initiative. The ACM agreed this is
a worthwhile project.
. Public Consultation on Xenotransplantation
(A. Mills / M. Law)
Due to time constraints, the slide presentation was distributed and
Marion Law gave a brief update. Health Canada has funded the Canadian
Public Health Association (CPHA) to conduct consultations on xenotransplantation
across Canada. The consultations (in 5 regions, Vancouver, Yellowknife,
Saskatoon, Halifax, Toronto and Quebec City) are set to begin as early
as March 2001, and are expected to be completed by the end of July 2001.
The report from CPHA is expected in November 2001.
. Clinical Trial Reform (D. Brodie)
The proposed amendments to Clinical Trial regulations are on hold due
to a lack of consensus. Research Ethics Boards for one remain concerned
about the shortened time period. Consumers are generally not supportive
of the proposals.
The Industry has proposed a 7 day default in response
to the Programme's proposal to 2 day (48 hour) target time. Generally,
Industry does not support administrative targets. Their position is
that the Programme often does not meet established target time. TPP
is waiting for further direction from the Minister's Office.
ACM agreed to express their concerns to the Minister
and invite him to come to the next meeting and address these issues.
Update on Chemistry and Manufacturing Review
- Backlog and proposed solutions (Marta Caris / Sultan Ghani)
Sultan Ghani presented the action plan to address the
backlog of submissions. Four review Units have been put in place to
manage the different submissions types. TPP is working with the manufacturers
to improve the quality of the submissions and working to maintain the
consistency and quality of the reviews. With the recent staffing of
new reviewers, it is expected that the backlog will be cleared in 3
to 6 months. The issue of contracting out was brought to the table.
Due to conflict of interest, the fact that chemistry and manufacturing
submissions contain protected manufacturing information, contracting
this activity is difficult. In some circumstances, retired TPP employees
are sometimes hired on contract to review submissions.
The consistent use of the clarifax was a problem, but
this is now resolved. This will ensure reviewers are keeping current
with new science in this area. A training programme is in place for
new staff and a refresher course, designed for existing staff has also
been established.
Guidance Documents: Guidance for Industry Preparation
of Drug Identification Number Submission (DINs/Quality Chemistry and
Manufacturing) Information, Review Template Quality Overall Summary
(Drug Identification Number Submission). The draft is now ready and
should be available by beginning of February. The backlog of submissions
in Chemistry and Manufacturing is an important issue and the ACM members
indicated that they would like another report at the next meeting. They
want to fully understand the situation in order to participate with
finding a solution.
9. Institute on Risk Management (A.
Baumann)
Andrea Baumann raised the issue regarding the need to
create and gather support for the establishment of an Institute to cover
research and risk management issues. A number of Institutes have been
established and successfully contribute to these areas.
Andrea proposed that the ACM could initiate discussions
around establishing Institute to address risk management issues. The
first step could be a letter to the Chief Scientist.
ACTION: Institute to contact the Chief
Scientist
10. Product Monograph (R. Duncan)
Ross Duncan (TPP) presented an update on the Product
Monograph (PM). He reviewed the outcomes of the consultation in September
and next steps from this consultation. The Programme is currently revising
the PM guidelines to reflect the new format. At the same time the Programme
will be exploring the issues of ownership and dissemination of this
document. ACM asked to be kept informed.
Product Monograph (continued)
Some issues raised by the ACM for consideration when
moving this project ahead include:
importance of establishing ownership
balancing the information to ensure it meets the needs of consumers
but does not prevent them using the medication (e.g. unclear information
about adverse effects)
timeliness of providing this information to consumers
12. Use of External Advisory Panels for Operational Issues and
Managing Conflict of Interest (R. Peterson)
TPP is considering extending the use of Expert Panels
to reviewing parts of drug submissions and participating in the decisions
on pre-market approval and post market issues. It was noted that Health
Canada does not use expert panels to the same exert as other comparable
regulatory agencies. The successful use of external expert panels depends
on the approval of management of potential conflict of interest. As
the ACM is an external body, Dr. Peterson asked this group to consider
this issue and work with the TPP to strengthen the process in place
to allow us to develop closer working relationships with external expert
panels. In conclusion, there was general agreement to the concept. TPP
will do an issue analysis and this will be discussed at the next ACM
meeting.
ACTION: TPP to prepare issue analysis
13. Discussion on Article: Tales from the Other Drug Wars
(R. Peterson)
Dr. Peterson introduced the document. TPP will be preparing
an analysis of this document. ACM is invited to provide comments to
the Director General on their opinions and reactions to the article.
The source is credible so the issue should be addressed. It was suggested
that ACM should confine comments to matters concerning the TPP. Other
related similar materials were published in L.A. Times and Globe and
Mail.
ACTION: ACM members to provide comments to TPP.
14. Meeting Evaluation and Closing
Again the members appreciated having fewer formal presentations
on the agenda. It allowed for more in-depth discussions on the different
issues with the presenters. It was suggested that following the meeting,
the minutes style with record of decisions was appropriate, but the
members would receive a report, providing a summary of discussions on
a number of issues that the committee will be pursuing in more depth.
Also, the members would like to receive the agenda in a timely fashion
before the formal meeting so that they can provide valuable input at
the meeting, and would also like to be kept abreast of issues as they
develop.
As an orientation tool for new members, and also to assist
the ongoing members, it was also suggested to create a binder containing
information such as general guidelines, organizational chart, list of
acronyms, major policy documents and the latest quarterly report. The
TPP will begin preparing this information to provide to members at the
next meeting.
At the next meeting, ACM will be serving 2 Directorates
(Therapeutic Products Programme and Biologics and Genetic Therapies).
Future Agenda Items:
- Mandate of ACM (within Re-alignment)
How can ACM bring advice to two new directorates?
- Invitation to Deputy Minister
- Invitation to Chief Scientist: his vision, etc.
- Chemistry and Manufacturing Review Issue
- Update on Human Resources
- Post-market surveillance
- Issues specific to clinical trial Reform
- Backlog issues
- Link to other Advisory Committees to TPP
- Policy to address off-label uses: considerations and impact
- How can we use foreign reviews to assist with Canadian reviews
- Public confidence and how this impacts on how TPP does its job
Next meeting: May 9 - 10, 2001 (10:00 a.m. start on May
9th)
TPP Boardroom, Room 2048, Holland Cross, Tower B
1600 Scott Street
Jim Blackburn
Chair
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